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A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis

N. Farkas, L. Hanák, A. Mikó, J. Bajor, P. Sarlós, J. Czimmer, Á. Vincze, S. Gódi, D. Pécsi, P. Varjú, K. Márta, PJ. Hegyi, B. Erőss, Z. Szakács, T. Takács, L. Czakó, B. Németh, D. Illés, B. Kui, E. Darvasi, F. Izbéki, A. Halász, V. Dunás-Varga,...

. 2019 ; 10 (-) : 1092. [pub] 20190904

Jazyk angličtina Země Švýcarsko

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc19035650

Background: C-reactive protein level (CRP) and white blood cell count (WBC) have been variably used in clinical trials on acute pancreatitis (AP). We assessed their potential role. Methods: First, we investigated studies which have used CRP or WBC, to describe their current role in trials on AP. Second, we extracted the data of 1435 episodes of AP from our registry. CRP and WBC on admission, within 24 h from the onset of pain and their highest values were analyzed. Descriptive statistical tools as Kruskal-Wallis, Mann-Whitney U, Levene's F tests, Receiver Operating Characteristic (ROC) curve analysis and AUC (Area Under the Curve) with 95% confidence interval (CI) were performed. Results: Our literature review showed extreme variability of CRP used as an inclusion criterion or as a primary outcome or both in past and current trials on AP. In our cohort, CRP levels on admission poorly predicted mortality and severe cases of AP; AUC: 0.669 (CI:0.569-0.770); AUC:0.681 (CI: 0.601-0.761), respectively. CRP levels measured within 24 h from the onset of pain failed to predict mortality or severity; AUC: 0.741 (CI:0.627-0.854); AUC:0.690 (CI:0.586-0.793), respectively. The highest CRP during hospitalization had equally poor predictive accuracy for mortality and severity AUC:0.656 (CI:0.544-0.768); AUC:0.705 (CI:0.640-0.769) respectively. CRP within 24 h from the onset of pain used as an inclusion criterion markedly increased the combined event rate of mortality and severe AP (13% for CRP > 25 mg/l and 28% for CRP > 200 mg/l). Conclusion: CRP within 24 h from the onset of pain as an inclusion criterion elevates event rates and reduces the number of patients required in trials on AP.

1st Department of Medicine University of Szeged Szeged Hungary

Bajcsy Zsilinszky Hospital Budapest Hungary

Borsod Abaúj Zemplén County Hospital University Teaching Hospital Miskolc Hungary

Centrum Péče o Zažívací Trakt Vítkovická Nemocnice a s Ostrava Czechia

Consorci Sanitari del Garraf Barcelona Spain

County Emergency Clinical Hospital University of Medicine Pharmacy Sciences and Technology of Targu Mures Targu Mures Romania

Department of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary

Department of Gastroenterology Bács Kiskun County Hospital Kecskemét Hungary

Department of Internal Medicine Division of Gastroenterology Faculty of Medicine University of Debrecen Debrecen Hungary

Department of Transplantation and Liver Surgery Helsinki University Central Hospital University of Helsinki Helsinki Finland

Dr Bugyi István Hospital Szentes Hungary

Dr Réthy Pál Hospital Békéscsaba Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary 1st Department of Medicine University of Szeged Szeged Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary Department of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary Department of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary 1st Department of Medicine University of Szeged Szeged Hungary Momentum Gastroenterology Multidisciplinary Research Group Hungarian Academy of Sciences University of Szeged Szeged Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary Heim Pál National Institute of Pediatrics Budapest Hungary Clinical Medicine Doctoral School University of Szeged Szeged Hungary

Institute of Bioanalysis Medical School University of Pécs Pécs Hungary Institute for Translational Medicine Medical School University of Pécs Pécs Hungary

Pándy Kálmán Hospital of County Békés Gyula Hungary

Saint Luke's Clinical Hospital St Petersburg Russia

School of Medicine Hospital of Bezmialem Vakif University Istanbul Turkey

Szent György University Teaching Hospital Fejér County Székesfehérvár Hungary

Vilnius University Hospital Santariskiu Klinikos Vilnius Lithuania

Citace poskytuje Crossref.org

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$a A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis / $c N. Farkas, L. Hanák, A. Mikó, J. Bajor, P. Sarlós, J. Czimmer, Á. Vincze, S. Gódi, D. Pécsi, P. Varjú, K. Márta, PJ. Hegyi, B. Erőss, Z. Szakács, T. Takács, L. Czakó, B. Németh, D. Illés, B. Kui, E. Darvasi, F. Izbéki, A. Halász, V. Dunás-Varga, L. Gajdán, J. Hamvas, M. Papp, I. Földi, KE. Fehér, M. Varga, K. Csefkó, I. Török, F. Hunor-Pál, A. Mickevicius, ER. Maldonado, V. Sallinen, J. Novák, AT. Ince, S. Galeev, B. Bod, J. Sümegi, P. Pencik, A. Szepes, A. Szentesi, A. Párniczky, P. Hegyi,
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$a Background: C-reactive protein level (CRP) and white blood cell count (WBC) have been variably used in clinical trials on acute pancreatitis (AP). We assessed their potential role. Methods: First, we investigated studies which have used CRP or WBC, to describe their current role in trials on AP. Second, we extracted the data of 1435 episodes of AP from our registry. CRP and WBC on admission, within 24 h from the onset of pain and their highest values were analyzed. Descriptive statistical tools as Kruskal-Wallis, Mann-Whitney U, Levene's F tests, Receiver Operating Characteristic (ROC) curve analysis and AUC (Area Under the Curve) with 95% confidence interval (CI) were performed. Results: Our literature review showed extreme variability of CRP used as an inclusion criterion or as a primary outcome or both in past and current trials on AP. In our cohort, CRP levels on admission poorly predicted mortality and severe cases of AP; AUC: 0.669 (CI:0.569-0.770); AUC:0.681 (CI: 0.601-0.761), respectively. CRP levels measured within 24 h from the onset of pain failed to predict mortality or severity; AUC: 0.741 (CI:0.627-0.854); AUC:0.690 (CI:0.586-0.793), respectively. The highest CRP during hospitalization had equally poor predictive accuracy for mortality and severity AUC:0.656 (CI:0.544-0.768); AUC:0.705 (CI:0.640-0.769) respectively. CRP within 24 h from the onset of pain used as an inclusion criterion markedly increased the combined event rate of mortality and severe AP (13% for CRP > 25 mg/l and 28% for CRP > 200 mg/l). Conclusion: CRP within 24 h from the onset of pain as an inclusion criterion elevates event rates and reduces the number of patients required in trials on AP.
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$a Márta, Katalin $u Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
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$a Erőss, Bálint $u Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary. Department of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary.
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$a Szakács, Zsolt $u Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
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$a Takács, Tamás $u First Department of Medicine, University of Szeged, Szeged, Hungary.
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$a Czakó, László $u First Department of Medicine, University of Szeged, Szeged, Hungary.
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$a Németh, Balázs $u First Department of Medicine, University of Szeged, Szeged, Hungary.
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$a Kui, Balázs $u First Department of Medicine, University of Szeged, Szeged, Hungary.
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$a Darvasi, Erika $u First Department of Medicine, University of Szeged, Szeged, Hungary.
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$a Izbéki, Ferenc $u Szent György University Teaching Hospital, Fejér County, Székesfehérvár, Hungary.
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$a Halász, Adrienn $u Szent György University Teaching Hospital, Fejér County, Székesfehérvár, Hungary.
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$a Bod, Barnabás $u Dr. Bugyi István Hospital, Szentes, Hungary.
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$a Sümegi, János $u Borsod-Abaúj-Zemplén County Hospital, University Teaching Hospital, Miskolc, Hungary.
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